The FDA has Issued a Recall for the Exactech Connexion (Hip Implant)

Serious questions about the safety of the Exactech Connexion GXL liner hip implant received major public attention in spring 2020. At that time, two important studies were published in well-regarded academic journals.
A study published in the The Journal of Arthroplasty reviewed more than ten years of data of patients who had significant osteolysis before receiving a hip implant. A significant percentage of patients were forced to undergo a revision surgery. After an in depth analysis of the data, the research concluded that patients who got the “Exactech Connexion GXL liner may be prone to a high rate of early failure from wear and severe secondary osteolysis.”

Soon after, a study published in the Arthroplasty Today was also focused on the safety of the Exactech Connexion GXL liner hip implant. In the study, researchers monitored and evaluated several dozen people who received hip implants. Unfortunately, they found that several people required a secondary revision surgery to correct a serious medical complication within the first five years of the date they received their implant. The medical researchers concluded that they observed a “concerning trend with the use of the Exactech Connexion GXL liner.”

More than one year after these studies were published for the public, the Florida-based medical device manufacturer Exactech took action and issued an initial product safety recall. For reference, the medical device company has estimated that more than 90,000 hip implants in the United States are subject to the product safety recall. Within the recall, the Exactech cited two main areas of concern:

To be effective, a hip implant must be properly balanced. Excess edge-loading occurs when too much of the contact point between the acetabular and femoral component extends off the “edge” of the hip implant, causing serious medical complications. Beyond excessive edge-loading, Exactech’s product safety recall notice also addressed premature prosthesis wear as an area of concern. Consistent with the academic studies published in 2020, the company found potential problems regarding premature degradation of its medical device.

Any person who has received the Exactech Connexion GXL liner hip implant that is subject to the recall—including specific hip implant devices such as the Exactech Acumatch®, Exactech MCS®; and the Exactech Novation®—should be aware of the potential risk, the possible side effects, and the early warning signs that suggest that there may be a serious problem. Among other things, the warning signs of edge-loading and/or premature prosthesis wear include:

With hip implant problems, it is crucial that patients take proactive steps to address any potential problems. Unfortunately, medical complications related to the Exactech Connexion GXL liner hip implant can gradually grow more severe. In many cases, patients who have received a defective Exactech Connexion GXL liner hip implant may require a secondary operation called a revision surgery. Doctors will determine if this operation is necessary for you or your loved one.

Medical device manufacturers have a legal responsibility to ensure that the products they are putting onto the market are correctly designed and manufactured, property tested, and reasonably safe for public use. Very serious medical complications can occur when companies cut corners on safety or otherwise put profits before people. Exactech and other major medical device makers can be liable for harm caused by dangerous and defective products.

A number of different product liability lawsuits have already been filed against Exactech. These legal claims allege that the company manufactured and sold dangerous and defective medical devices (Exactech Connexion GXL liner hip implants) that caused tangible harm to patients. Further, these legal claims allege that the company knew or should have known about the product safety defects earlier. Lawsuits allege an improper and negligent delay in recall by the company harmed people.

If you received an Exactech Connexion GXL hip liner and you suffered medical complications, you may be entitled to financial compensation for your damages. Most notably, if you have been required to undergo a revision operation or if you will be undergoing a revision operation in the future, you should consult with an experienced defective medical device attorney. Exactech may be legally responsible for your injuries and medical complications. Your legal claim should be investigated as soon as possible. You may be entitled to compensation for the full extent of your damages, including for medical bills, physical therapy, lost wages, pain and suffering, and permanent disability or long-term physical impairment.

Bernheim Kelley Battista & Bliss, LLC is a leading product liability firm that has experience handling a wide range of defective medical device claims. Contact the legal team today to request a no cost, fully confidential initial appointment with an experienced defective medical device attorney. From their law offices in Florida and Massachusetts,  Bernheim Kelley Battista & Bliss provide local and nationwide representation in defective Exactech Connexion hip implant claims.